§ 40.91 What validity tests must laboratories conduct on primary specimens?
Wording in the annual edition revised as of Oct. 1, 2001, superseded by the 2005 annual edition.
Non-evidentialAs alcohola screeninglaboratory, testswhen you conduct validity testing under § 40.89, performedyou usingmust screeningconduct devicesit includedin byaccordance with the Nationalrequirements Highwayof Trafficthis Safetysection.
(a) AdministrationYou onmust itstest conformingeach productsprimary listspecimen for non-evidentialcreatinine. screeningYou devices,must also determine its specific gravity if you find that the creatinine concentration is less than 20 mg/dL.
(b) You must measure the pH of each primary specimen.
(c) You must test each primary specimen to determine if it contains substances that may be used to adulterate the specimen. Your tests must have the capability of determining whether any substance identified in lieucurrent HHS requirements or specimen validity guidance is present in the specimen.
(d) If you suspect the presence of EBTsan interfering substance/adulterant that could make a test result invalid, but you are unable to performidentify screeningit tests(e.g., requireda bynew operatingadulterant), administrations’you alcoholmust, testingas regulationsthe first laboratory, send the specimen to another HHS certified laboratory that has the capability of doing so.
(e) Non-evidentialIf screeningyou devicesidentify maya notsubstance bein useda forspecimen confirmationthat alcoholappears teststo be an adulterant, but which mustis benot conductedlisted usingin EBTscurrent asHHS providedrequirements or guidance, you must report the finding in subpartwriting Cto ODAPC and the Division of thisWorkplace partPrograms, HHS, within three business days. You must also complete testing of the specimen for drugs, to the extent technically feasible.
(f) You must conserve as much as possible of the specimen for possible future testing.
As a laboratory, when you conduct validity testing under § 40.89, you must conduct it in accordance with the requirements of this section.
(a) You must test each primary specimen for creatinine. You must also determine its specific gravity if you find that the creatinine concentration is less than 20 mg/dL.
(b) You must measure the pH of each primary specimen.
(c) You must test each primary specimen to determine if it contains substances that may be used to adulterate the specimen. Your tests must have the capability of determining whether any substance identified in current HHS requirements or specimen validity guidance is present in the specimen.
(d) If you suspect the presence of an interfering substance/adulterant that could make a test result invalid, but you are unable to identify it (e.g., a new adulterant), you must, as the first laboratory, send the specimen to another HHS certified laboratory that has the capability of doing so.
(e) If you identify a substance in a specimen that appears to be an adulterant, but which is not listed in current HHS requirements or guidance, you must report the finding in writing to ODAPC and the Division of Workplace Programs, HHS, within three business days. You must also complete testing of the specimen for drugs, to the extent technically feasible.
(f) You must conserve as much as possible of the specimen for possible future testing.
Amendment history
5 distinct wordings on file since Oct. 1, 1996- [88 FR 27643, May 2, 2023]
- [65 FR 79526, Dec. 19, 2000, as amended at 69 FR 64867, Nov. 9, 2004]
- [65 FR 79526, Dec. 19, 2000, as amended at 69 FR 64867, Nov. 9, 2004]
- Oct. 1, 1996 → Oct. 1, 2001annual editions 1996–2000
A new entry appears whenever the regulatory words change between government snapshots. Day-precise from the eCFR (2017 onward); before that, one snapshot per annual CFR edition (revised as of October 1). Bracketed citations are the Federal Register history printed with the section.